A Study of MSI-1256F (Squalamine Lactate) To Treat "Wet" Age-Related Macular Degeneration
- Conditions
- Macular Degeneration
- Registration Number
- NCT00333476
- Lead Sponsor
- Genaera Corporation
- Brief Summary
Age-Related Macular Degeneration (AMD) is a degenerative eye disease of the retina that causes a progressive loss of central vision. AMD is the leading cause of legal blindness among adults age 50 or older in the Western world. AMD presents in two different types - "dry" and the more severe "wet" form. Wet AMD is caused by the growth of abnormal blood vessels in the macula. Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels. This study will test the safety and efficacy of Squalamine in the treatment of AMD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 140
- Adult subjects ≥ 50 years of age.
- minimally classic or active occult choroidal neovascularization associated with age-related macular degeneration in one or both eyes.
- baseline best corrected visual acuity score between 35 to 65 letters according to the Early Treatment of Diabetic Retinopathy Study protocol.
- central retinal thickness by optical coherence tomography of > 250 microns.
- lesions > 9 disc areas.
- > 25% fibrosis in the lesion.
- Previous history of triamcinolone, bevacizumab, ranibizumab, or pegaptanib sodium injection therapy in the study eye.
- retinal or optic nerve disease.
- uncontrolled diabetes.
- ongoing malignancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the safety profile of squalamine lactate at doses ranging from 40 mg to 160 mg of squalamine lactate
- Secondary Outcome Measures
Name Time Method To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by optical coherence tomography To evaluate short-term effects on best corrected visual acuity and changes in subretinal CNV as measured by fluorescein angiography
Related Research Topics
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Trial Locations
- Locations (9)
Florida Eye Microsurgical Institute
🇺🇸Boynton Beach, Florida, United States
Retina Health Center
🇺🇸Fort Meyers, Florida, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Retina Specialists
🇺🇸Towson, Maryland, United States
Eye Foundation of Kansas City
🇺🇸Kansas City, Missouri, United States
Ophthalmic Consultants of Long Island
🇺🇸Long Island, New York, United States
Retina Associates of Western New York
🇺🇸Rochester, New York, United States
Charles Garcia, MD, P.A.
🇺🇸Houston, Texas, United States
Florida Eye Microsurgical Institute🇺🇸Boynton Beach, Florida, United States